IPA FOR DETECTION OF PHENOBARBITAL— 510(k) K821543
Substantially EquivalentElectro-Nucleonics Laboratories, Inc.
FDA 510(k) clearance K821543 for IPA FOR DETECTION OF PHENOBARBITAL, Substantially Equivalent on 1982-06-03. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Product code
- Code LFN
- Device class
- Class 2
- Regulation
- 21 CFR 862.3660
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code LFN
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